Lead Responsible for but not limited to: Approval or rejection of materials and reagents, intermediates, bulk and finished products in accordance to specifications.
Evaluation of batch records as part of the release process that meets specifications.
Evaluation of deviation reports relating to manufacturing, premises, equipment and documentation.
Ensures release testing has been performed and appropriate documentation is generated and stored with the batch records.
Conducts regular internal audits and self-inspections.
Implementation and development of electronic QMS in cooperation with GMP director Develops checks and maintains quality department, premises and equipment.
Ensures initial and continuous training of QC personnel.
Development and implementation of the GMP quality manual.
Develops and implements clinical supply chain procedures in cooperation with Management.
Coordinates and oversees operational compliance monitoring activities, including providing subject matter expertise to address/resolve quality and compliance related questions.
Lead Continuous Improvement projects
Assist in completing investigations, deviations, Out-of-specification reports, etc.
Assist in developing robust CAPAs to minimize reoccurrence of non-conformances and to prevent potential systemic compliance issues.
Quality Representative in Functional Area Team Meetings, serving as the go-to person answering quality related questions.
Author, review and/or approve related documents and records, such as for example, SOPs, Work Instructions, IQ/OQ/PQ, Analytical Test Methods, Specifications, etc
Assists and facilitate information in support of regulatory facility audits and inspections as needed. Implement the Change Management process by authoring and managing change controls.
Review and approve Validation Plans and Scientific Investigation Reports SIRs , including raw data review of lab test results.
Create and deliver training modules of quality topics.
Facilitate training related activities from a quality standpoint.
Should be highly knowledgeable in cGMPs, GLPs, GDPs e.g., FACT and FDA
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